Former FDA Scientist Claims Agency Superiors Downplayed His Pre-approval Concerns About Safety of Ketek
(Posted by Tom Lamb at DrugInjuryWatch.com)
In a February 8, 2007 Bloomberg article, Justin Blum reported on his interview with former FDA scientist David Ross, done in the days leading up to the testimony which Ross gave before the House Subcommittee on Oversight and Investigations.
According to Blum's article, during this interview Ross alleged that:
... FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections....
Ross said some of his suggestions were shaped by the way the FDA responded to his findings about Ketek when he was a medical team leader. He wrote in a safety review that the drug's risks appeared too great to allow approval for treatment of bronchitis and sinusitis, two common respiratory infections.
"I was called into my division director and told to 'soften my review,'" Ross said. He changed the wording to be more "neutral," he said. "When I made scientific arguments, they were ignored when there was an economic argument for the company."
Despite the safety concerns expressed by Ross, Ketek was approved in April 2004 as a treatment for bronchitis, sinusitis, and community-acquired pneumonia.
In December 2006, however, an FDA advisory panel seemingly vindicated the pre-approval position taken by Ross when it recommended that Ketek should not be prescribed for bronchitis and sinusitis because this Sanofi-Aventis antibiotic had been associated with reports of serious liver damage. Moreover, in February 2007 the FDA announced that it was adopting this advisory panel recommendation and withdrawing its earlier approval of Ketek for treatment of bronchitis and sinusitis.
During his February 12, 2007 testimony on Capitol Hill about how the FDA was performing its drug oversight mission, David Ross was even more pointed in his criticism of the agency. A February 13, 2007 USA Today article about this Congressional hearing included this coverage:
"FDA approved Ketek, despite knowing that it could kill people from liver damage and that tens of millions of people would be exposed to it," physician David Ross, who had worked on the pre-approval side of FDA's Center for Drug Evaluation and Research (CDER) for a decade, told the panel. Ross said his superiors forced him to soften his unflattering review of the drug.
According to this same USA Today article, the February 12 hearing before the House Committee on Oversight and Investigations is only the first in a series that will evaluate how the FDA is doing as regards the approval of new drugs and the monitoring of those drugs for emerging safety issues following approval. Given that the manner in which the FDA has handled Ketek on both fronts, it seems likely that there will be more testimony forthcoming about this controversial antibiotic from Sanofi-Aventis.